PlayMakar Sport Muscle Stimulator, Model PRO-500
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182581 FDA 510(k)
- FDA Product Code
- NUH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PlayMakar Sport Muscle Stimulator, Model PRO-500 is a dual-channel electrotherapy device that delivers up to 80mA of medical-grade output using a symmetrical bi-phasic square waveform to recruit motor neurons effectively while maintaining patient comfort. It is designed to support anticipated disturbances originating from electrostatic discharge, magnetic fields for the power supply, or radio frequency interference.
The device is supplied with 10 pre-set programs designed to help improve muscle warm-up, build strength, assist recovery, maximize endurance, and manage pain. It received FDA 510(k) clearance under K182581 with product code NUH and was found substantially equivalent to a predicate device. The device is manufactured by Playmakar, Inc. and is intended for use in settings where electrotherapy is indicated for neuromuscular stimulation.
Frequently asked questions
What is the PlayMakar Sport Muscle Stimulator PRO-500 used for?
It is designed to support neuromuscular stimulation by delivering electrotherapy to improve muscle warm-up, build strength, assist recovery, maximize endurance, and manage pain through its 10 pre-set programs.
How is the PlayMakar Sport Muscle Stimulator PRO-500 supplied and what does it include?
The device is supplied as a dual-channel electrotherapy unit with the PRO-500 model, including the stimulator and associated components necessary for operation, as indicated in its FDA 510(k) submission.
Is the PlayMakar Sport Muscle Stimulator PRO-500 intended for single-use or repeated use?
As a reusable electrotherapy device designed for multiple treatment sessions across various programs, it is intended for repeated use in clinical or sport settings where electrotherapy is indicated.
What regulatory pathway was used for the PlayMakar Sport Muscle Stimulator PRO-500?
The device received FDA 510(k) clearance under K182581, demonstrating substantial equivalence to a predicate device with product code NUH.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PlayMakar SPORT Muscle Stimulator (PRO-500) - MedGrade, SPORT Muscle Stimulator with Explosive Strength Mode - PlayMakar, PDF PlayMakar Sport Muscle Stimulator [PRO-500] User Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182581 | Class II | Active |
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Manufacturer
- Manufacturer
- Playmakar, Inc.
Sources (1)
- FDA 510(k) K182581 24 fields · synced Sep 22, 2026